BioXcel Announces Positive Topline Results in Schizophrenia Study

BioXcel Therapeutics (Nasdaq: BTAI) has reported positive topline results from a post-marketing requirement (PMR) study of its IGALMI™ (dexmedetomidine) sublingual film treatment for schizophrenia. The study demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with the 180 mcg dose after seven days of PRN (as-needed) treatment.

The single-arm, open-label study enrolled 28 inpatient adults with frequent episodes of agitation associated with bipolar disorders or schizophrenia. Patients self-administered 180 mcg dose of IGALMI™ as needed over seven days. A total of 83 episodes were treated.

Vincent O’Neill, M.D., Chief of Product Development and Medical Officer of BioXcel Therapeutics, commented, “We are encouraged by these study results showing a lack of tachyphylaxis, tolerance, and withdrawal at the highest approved dose of IGALMI for patients experiencing frequent episodes of agitation. This new dataset may help address potential changes to the language in the current label. This dataset also adds to our body of evidence for our lead neuroscience asset as we prepare to advance our Phase 3 SERENITY and TRANQUILITY trials.”

The 180 mcg dose of IGALMI™ was generally well tolerated and showed favorable safety results in treating patients with frequent episodes of agitation.

IGALMI™ (dexmedetomidine) sublingual film is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults.

About BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit

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BioXcel Announces Positive Topline Results in Schizophrenia Study

Catie Corcoran

Biotech Editor